Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on Heart Rate Variability

Last updated: March 10, 2025
Sponsor: GCS CIPS
Overall Status: Suspended

Phase

N/A

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

repetitive transcranial magnetic stimulation

Clinical Study ID

NCT06451809
DEP&MOD
  • Ages > 18
  • All Genders

Study Summary

Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having a prescription for a course of rTMS to treat an episod of MDD

  • Unipolar MDD confirmed according to DSM-5 criteria

  • Moderate to severe MDD (MADRS score > 19)

  • No use of psychotropic medication or use stabilised (no change in dose < 4 weeksbefore study entry)

  • Able to understand, speak, read and write French

  • Express informed consent, after a period of reflection

  • Affiliated with a French social security scheme or beneficiary of such a scheme

Exclusion

Exclusion criteria:

  • History of epilepsy or convulsive seizures

  • Previous brain surgery

  • History of recent cranial trauma (< 6 months)

  • Presence of severe suicidal ideation

  • Psychotic disorders

  • Metal objects in the head, eyes or brain

  • Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)

  • Clinical evidence of serious or uncontrolled alcohol or substance use disorders inthe three months prior to the study

  • Active withdrawal from alcohol or other substances

  • One or more recent rTMS sessions (< 4 weeks)

  • Other non-drug therapy recently initiated (< 4 weeks) to treat MDD (psychotherapy,phototherapy, vagus nerve stimulation, etc.)

  • Prescription of cardiotropic drugs belonging to the following classes: predominantlycardiac calcium channel blockers, Vaughan Williams class I anti-arrhythmics andbeta-blockers.

  • Subjects in a period of relative exclusion from another protocol

  • Adults protected by law or patients under guardianship or curatorship

  • Subjects deprived of their liberty by judicial or administrative decision

  • Pregnant or breast-feeding women

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: repetitive transcranial magnetic stimulation
Phase:
Study Start date:
June 13, 2024
Estimated Completion Date:
June 01, 2025

Study Description

The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (MDD) with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires weekly and after the final rTMS session to track the progression of depressive symptoms.

Connect with a study center

  • Clinique Inicea du Pays de Seine

    Bois-le-Roi, 77590
    France

    Site Not Available

  • Clinique Inicea La Mare O Dans

    Les Damps, 27340
    France

    Site Not Available

  • Clinique Inicea Villa des Roses

    Lyon, 69005
    France

    Site Not Available

  • Etablissement public de santé de Ville-Evrard

    Neuilly-sur-Marne, 93330
    France

    Site Not Available

  • Centre médical de psychiatrie NeuroStim Etoile

    Paris, 75016
    France

    Site Not Available

  • Centre médical de psychiatrie NeuroStim Luxembourg

    Paris, 75005
    France

    Site Not Available

  • Clinique Inicea Jeanne d'Arc Hopital Privé Parisien

    Saint-Mandé, 94160
    France

    Site Not Available

  • Centre montois de psychiatrie ambulatoire Inicea

    Saint-Pierre-du-Mont, 40280
    France

    Site Not Available

  • Centre Tourangeau de psychiatrie ambulatoire Inicea

    Tours, 37000
    France

    Site Not Available

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